1. The Field of the Invention
This invention relates generally to a digital amniotome, and more particularly to a digital amniotome with a directional indicator to facilitate the orientation of an attached sharp-tipped element.
2. Technical Background
The amniotic membrane is the sac surrounding the fetus in a pregnant woman's womb. In order to hasten labor and delivery, it is often desirable to artificially break the amniotic membrane. To accomplish this, a membrane-rupturing device is often inserted into the cervix through the vagina. One method is to have the membrane-rupturing device either attached to a finger or integral with a surgical glove. Such device is introduced into the cervix via the finger. Several finger-attachment and surgical glove devices are known in the art for rupturing amniotic membranes. Preferably, such devices would allow the user to maintain finger-sensitivity--allowing determination of the proper location to rupture the membrane. Also, preferably, the device would not damage other membranes or tissues, it would be operable with a single finger, and it would be simple to manufacture and use.
A finger sheath device is known in the art that has a small, sharp-tipped element attached to the interior surface of the distal end of the finger-sheath. The sharp-tipped element of this device is directional, i.e., the sharp-tipped element has both a cutting edge and a smooth edge. However, because the element is small, and there are no directional indicators on the device, it is difficult for a user to determine the orientation of the sharp-tipped element. The device lacks directional indicators because the base upon which the element sits is round, the hole through which the sharp-tipped element extends is round, and the base is approximately the same color as the finger-sheath. If the device is not properly oriented on the user's finger, it is difficult or impossible to use correctly.
Several other more complicated devices are also known in the art. Many comprise surgical gloves having modifications or attachments for rupturing an amniotic membrane. One such device includes a surgical glove having a hook on one side of the long finger. The hook is normally retracted, but it is extendible by the index finger in order to rupture the amniotic membrane. This device is limited in its application and is relatively difficult to operate; it requires sufficient dilation of the cervical opening for the user to insert at least two fingers through the cervical opening, and it also requires that the user be able to maneuver the index finger to engage the hook and hold it in an extended position while rupturing the membrane.
Another surgical glove is known that has a flexible sheath along the back surface of the glove. The sheath includes a retractable, flexible blade that is enclosed in the sheath and is extendable via a button on the top of the sheath. The button must be pressed by an adjacent finger. This device is both complex to manufacture and is complicated to operate. It requires at least two fingers to operate, requiring one finger to press a button on top of another finger. Also, the blade may cause injury to other tissue upon removal from the cervix and vagina.
Yet another surgical glove includes a finger attachment having a tapered metal pin for rupturing membranes. Although the pin is positioned to minimize damage to other membranes, because the pin is always operable, i.e., it is neither retractable nor directionally oriented, damage to other membranes is risked. Furthermore, because the pin is metal, there would be manufacturing obstacles in securing a metal pin to an elastomeric surgical glove.
Although a simple surgical glove with a hard, cone-shaped element enclosing the tip of a finger is known, because the hard element entirely encloses the finger, the finger would have no sensitivity to touch during the procedure. Thus, the finger could not feel for the proper position to rupture the membrane. Also, because the sharp tip is not directionally oriented, but rather is cone-shaped, there would be a risk of damaging any other membrane or tissues that the end of the finger contacted.
In addition to surgical glove devices, many finger-attachment devices are also known in the art. For instance, a ring-like device is known with a guard adjacent to a recessed portion positioned over the pad of the fingertip. The recessed portion is resilient and has a sharp-tipped element that is deployed when pressure is applied to the guard. Although the device would allow finger-sensitivity for determining the appropriate rupturing location, the device would be relatively complex to both manufacture and operate.
Similarly, a finger sheath is known that is made of stiffly flexible material and has a recessed sharp-tipped element that is extendible upon finger flexion. Because the device is made with stiffly flexible material, it would not permit sufficient finger-sensitivity to ensure proper positioning of the device, thus damage to other membranes would be risked. Additionally, this device would be relatively complex to manufacture and operate due to the retractable sharp-tipped element.
It will be appreciated that it would be an advancement in the art to provide a digital amniotome with a directional indicator that facilitates the proper orientation of the directionally oriented sharp-tipped element. It would be a further advancement in the art to provide such a device that is also simple to manufacture and operate.